MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number G48027

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 10/19/2017

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # "k101530 and k163468".(b)(4).The complaint information reported was as follows: ¿endoscopic duodenal stent placement was performed.At the end of stent deployment, anterior wall mucosa of gastric antrum lacerated due to expansion of stent.Stent was placed between descending part of duodenum and stomach.Laceration area was closed using hemostasis clip.(also some area where the stent tip was placed lacerated more or less, however, since it was back side of the stent so the clip could not be placed.) transnasal gastric tube was placed for decompression.Conservative treatment was chosen, not surgical operation, so it has been taken wait-and-see approach.¿ physician provided the following comments: ¿i think laceration occurred at the last moment of stent expansion due to radial force of stent.I think the same thing will happen even another stent is used because the target patient of duodenum stent placement whose mucosa may be fragile due to cancer invasion.Stent placement itself was successful, and i recognize that there was no stent defect.¿ rep provided the following comments: ¿since the physician is experienced, it is difficult to determine if it was occurred by his procedure.¿ additional information which was requested was provided by the rep: "does laceration mean perforation? if not please elaborate.The mucosa was torn, not perforated.The user clipped the torn part.White coat has formed at the torn area which could not be clipped because it was located in the back side of the stent.It's healing well.Was the patient undergoing chemo/radiotherapy prior to this event? it's unknown.The user just commented as 'many patients who need duodenum stent placement has fragile mucosa'.Is there imaging available? no imaging is available.The patient has deceased recently.However the doctor commented as the cause of death was not this stent placement or the tear of the mucosa." it is understood from the information provided that the device was not the cause of the patient death or the tear in the mucosa that the tear was due to fragile patient anatomy and the death of the patient was unrelated also to the tear.The device involved in this complaint was not available for return to cook ireland for evaluation.Clinical had the following feedback: ¿anterior wall mucosa of gastric antrum laceration occurred at the end of stent deployment.A laceration is a traumatically induced event that results in mucous membrane in this case, it may not necessarily mean perforation which is caused by a disease process or operating procedure with penetration of a surface.Perforation (secondary to laceration) is normally severer than laceration and is listed complication as per the ifu.It means ifu covers the worse complication than laceration.Laceration occurred after stent deployment and laceration area was closed using hemostasis clip.¿conservative treatment was chosen, not surgical operation¿ means no immediate severe post-procedural harm occurred due to the laceration.¿laceration occurred at the last moment of stent expansion due to radial force of stent¿ per physician¿s comments, however, stent placement itself was successful, and there was no stent defect.Furthermore, engineer assessment confirmed that ¿stent falls within parameters of radial force therefore radial force would not be excessive¿.¿many patients who need duodenum stent placement has fragile mucosa¿ due to cancer invasion as the user commented, and the cause of death was not this stent placement or the tear of the mucosa per physician¿s conclusion.In summary, this patient¿s death was not associated with this stent placement.¿ as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.The doctor has commented that the cause of death was not this stent placement or the tear of the mucosa with the information provided a document based investigation was carried out.As per discussion with engineering and senior product manager and also from clinical feedback, perforation is a listed complication as per the ifu.From the information provided: ¿stent placement itself was successful¿ and ¿there was no stent defect.¿ ¿i think the same thing will happen even another stent is used because the target patient of duodenum stent placement whose mucosa may be fragile due to cancer invasion.¿ cirl engineering had the following comments: ¿stent falls within parameters of radial force therefore radial force would not be excessive.¿ from the information available and clinical feedback, the most probable cause may be due to fragile patient anatomy.Note: the doctor has commented that the cause of death was not this stent placement or the tear of the mucosa.The customer complaint is considered to be confirmed based on customer testimony.Prior to distribution, all evo devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for this evolution device of lot c1323119 revealed no discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot, upon review of complaints this failure mode has not occurred previously with this lot #.As per instructions for use, potential complications section: ¿those associated with gi endoscopy include, but are not limited to: perforation, haemorrhage, aspiration, respiratory depression or arrest, cardiac arrhythmia or arrest.¿ on review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.From the information provided, ¿transnasal gastric tube was placed for decompression.Conservative treatment was chosen, not surgical operation, so it has been taken wait-and-see approach.¿ patient died which was clarified not to be related to the stent placement or the tear of the mucosa.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This report is being submitted based on the requirement of surgical intervention.This report is only related to the clipping that occurred during the procedure ¿ this is a conservative assessment based on procedural intervention as the contributory involvement of the device related to the intervention is not confirmed (but not ruled out categorically either).Endoscopic duodenal stent placement was performed.At the end of stent deployment, anterior wall mucosa of gastric antrum lacerated due to expansion of stent.Stent was placed between descending part of duodenum and stomach.Laceration area was closed using hemostasis clip.(also some area where the stent tip was placed lacerated more or less, however, since it was back side of the stent so the clip could not be placed.) transnasal gastric tube was placed for decompression.Conservative treatment was chosen, not surgical operation, so it has been taken wait-and-see approach.Additional information provided on nov-09-2017: the mucosa was torn, not perforated.White coat has formed at the torn area which could not be clipped because it was located in the back side of the stent.It's healing well.However the patient has been deceased recently.The doctor commented as the cause of death was not this stent placement or the tear of the mucosa.It's unknown if the patient was undergoing chemo/radiotherapy prior to this event.The doctor just commented as 'many patients who need duodenum stent placement have fragile mucosa'.No imaging is available.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7036878
• MDR Text Key: 92196347
• Report Number: 3001845648-2017-00543
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)190206(10)C1323119
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention